Clincosm LogoSign in Get a demo

Microbiome/Peptidome-based Model for Non-invasive Detection of High-risk Gastroesophageal Varices in Compensated Cirrhosis (CHESS1901/APPHA1901)

Sponsor
Nanfang Hospital of Southern Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03990753
Collaborator
Southern Medical University, China (Other), LanZhou University (Other), Zhongda Hospital, Medical School, Southeast University (Other), Guangdong Second Provincial General Hospital (Other), Xingtai People's Hospital (Other), The Third Hospital of Zhenjiang Affiliated Jiangsu University (Other), Tianjin Second People's Hospital (Other), Zhejiang University Lishui Hospital (Other), The Second Hospital of Anhui Medical University (Other), The Sixth People's Hospital of Shenyang (Other), Xi'an Gaoxin Hospital (Other), King Chulalongkorn Memorial Hospital affiliated to Chulalongkorn University (Other), Ankara University (Other)
1,000
Enrollment
14
Locations
36
Anticipated Duration (Months)
71.4
Patients Per Site
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Variceal hemorrhage is a lethal complication in patients with cirrhosis and portal hypertension. Identification of varices needing treatment in compensated cirrhosis is, therefore, of great therapeutic and prognostic importance. The gold standard for diagnosing gastroesophageal varices and evaluating the risk of variceal hemorrhage is esophagogastroduodenoscopy. According to the Baveno VI consensus, for those with high-risk varices (HRV), either non-selective beta blockers or endoscopic band ligation is recommended for the prevention of the first variceal bleeding. However, the invasiveness and uncomfortableness during the esophagogastroduodenoscopy procedure has hindered its use in clinical practice, especially in patients with compensated cirrhosis. Sufficient accurate non-invasive tools for detection of HRV are warranted to safely avoid the use of esophagogastroduodenoscopy.

Advanced technologies including next-generation sequencing and MALDI-TOF mass spectrometry have the potential to be applied in this field. The latter is a widespread adopted tool in clinical microbiology for rapid, accurate and cost-effective identification of cultured bacteria and fungi. Recently, microbiome and peptidome have been proved their roles in the end-stage liver disease (e.g. cirrhosis, hepatocellular carcinoma), which may exhibit predictive capacity of HRV. In the present study, the investigators aim to conduct a prospective, multicenter diagnostic trial in 12 sites in China, 1 site in Turkey and 1 site in Thailand to evaluate the diagnostic performance of the microbiome/peptidome-based model for HRV detection in compensated cirrhosis.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: esophagogastroduodenoscopy

Detailed Description

Variceal hemorrhage is a lethal complication in patients with cirrhosis and portal hypertension. Identification of varices needing treatment in compensated cirrhosis is, therefore, of great therapeutic and prognostic importance. The gold standard for diagnosing gastroesophageal varices and evaluating the risk of variceal hemorrhage is esophagogastroduodenoscopy. According to the Baveno VI consensus, for those with high-risk varices (HRV), either non-selective beta blockers or endoscopic band ligation is recommended for the prevention of the first variceal bleeding. However, the invasiveness and uncomfortableness during the esophagogastroduodenoscopy procedure has hindered its use in clinical practice, especially in patients with compensated cirrhosis. Sufficient accurate non-invasive tools for detection of HRV are warranted to safely avoid the use of esophagogastroduodenoscopy.

Advanced technologies including next-generation sequencing and MALDI-TOF mass spectrometry have the potential to be applied in this field. The latter is a widespread adopted tool in clinical microbiology for rapid, accurate and cost-effective identification of cultured bacteria and fungi. Recently, microbiome and peptidome have been proved their roles in the end-stage liver disease (e.g. cirrhosis, hepatocellular carcinoma), which may exhibit predictive capacity of HRV. In the present study, the investigators aim to conduct a prospective, multicenter diagnostic trial in 12 sites (The First Hospital of Lanzhou University; Zhujiang Hospital of Southern Medical University; Nanfang Hospital of Southern Medical University; Xingtai People's Hospital; Zhongda Hospital, Medical School, Southeast University; The Third People's Hospital affiliated to Jiangsu University; Guangdong Second Provincial General Hospital; Tianjin Infectious Disease Hospital; Lishui Municipal Central Hospital; The Second Hospital of Anhui Medical University; Xi'an Gaoxin Hospital; The Sixth People's Hospital of Shenyang) in China, 1 site (Ankara University School of Medicine) in Turkey and 1 site (King Chulalongkorn Memorial Hospital affiliated to Chulalongkorn University) in Thailand to evaluate the diagnostic performance of the microbiome/peptidome-based model for HRV detection in compensated cirrhosis.

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Microbiome/Peptidome-based Model for Non-invasive Detection of High-risk Gastroesophageal Varices in Compensated Cirrhosis (CHESS1901/APPHA1901): A Prospective Multicenter Study
Actual Study Start Date :
Jun 13, 2019
Actual Primary Completion Date :
Jun 12, 2021
Anticipated Study Completion Date :
Jun 12, 2022

Arms and Interventions

Arm Intervention/Treatment
Overall eligible participants

Eligible participants will receive standard esophagogastroduodenoscopy and microbiome/peptidome examination.

Diagnostic Test: esophagogastroduodenoscopy
standard esophagogastroduodenoscopy

Outcome Measures

Primary Outcome Measures

  1. Diagnostic performance of microbiome/peptidome-based model for high-risk varices [1 day]

    Diagnostic performance of microbiome/peptidome-based model to determine the presence or absence of high-risk varices when compared with esophagogastroduodenoscopy as the reference standard

Secondary Outcome Measures

  1. Diagnostic performance of microbiome/peptidome-based model for decompensation or death [3 years]

    Diagnostic performance of microbiome/peptidome-based model to determine the presence or absence of decompensation (defined as development of ascites, bleeding, or overt encephalopathy) or death within 3-year follow-up

  2. Diagnostic performance of microbiome/peptidome-based model for hepatic venous pressure gradient [1 day]

    Diagnostic performance of microbiome/peptidome-based model to determine the level of hepatic venous pressure gradient

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • age 18-75 years;

  • confirmed compensated cirrhosis based on liver biopsy or clinical findings;

  • without decompensated events (e.g. ascites, bleeding, or overt encephalopathy);

  • scheduled to undergo esophagogastroduodenoscopy;

  • estimated survival time> 24 months, and model for end-stage liver disease (MELD) score< 19, and without liver transplant;

  • with written informed consent.

Exclusion Criteria:

  • contradictions for esophagogastroduodenoscopy;

  • use of antibiotics, prebiotics, probiotics and proton pump inhibitors within 3 months upon recruitment.

  • pregnancy or unknown pregnancy status.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Second Affiliated Hospital of Anhui Medical University Hefei Anhui China
2 The First Hospital of Lanzhou University Lanzhou Gansu China
3 Guangdong Second Provincial General Hospital Guangzhou Guangdong China
4 Nanfang Hospital of Southern Medical University Guangzhou Guangdong China
5 Zhujiang Hospital of Southern Medical University Guangzhou Guangdong China
6 Xingtai People's Hospital Xingtai Hebei China
7 Zhongda Hospital, Medical School, Southeast University Nanjing Jiangsu China
8 The Third Hospital of Zhenjiang Affiliated Jiangsu University Zhenjiang Jiangsu China
9 The Sixth People's Hospital of Shenyang Shenyang Liaoning China
10 Xi'an Gaoxin Hospital Xi'an Shanxi China
11 Tianjin Second People's Hospital Tianjin Tianjin China
12 Zhejiang University Lishui Hospital Lishui Zhejiang China
13 King Chulalongkorn Memorial Hospital affiliated to Chulalongkorn University Bangkok Thailand
14 Ankara University School of Medicine Ankara Turkey

Sponsors and Collaborators

  • Nanfang Hospital of Southern Medical University
  • Southern Medical University, China
  • LanZhou University
  • Zhongda Hospital, Medical School, Southeast University
  • Guangdong Second Provincial General Hospital
  • Xingtai People's Hospital
  • The Third Hospital of Zhenjiang Affiliated Jiangsu University
  • Tianjin Second People's Hospital
  • Zhejiang University Lishui Hospital
  • The Second Hospital of Anhui Medical University
  • The Sixth People's Hospital of Shenyang
  • Xi'an Gaoxin Hospital
  • King Chulalongkorn Memorial Hospital affiliated to Chulalongkorn University
  • Ankara University

Investigators

  • Principal Investigator: Hongwei Zhou, PhD, Southern Medical University, China
  • Principal Investigator: Xiaolong Qi, MD, LanZhou University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Xiaolong Qi, Professor, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier:
NCT03990753
Other Study ID Numbers:
  • CHESS1901
First Posted:
Jun 19, 2019
Last Update Posted:
Aug 17, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Xiaolong Qi, Professor, Nanfang Hospital of Southern Medical University
Microbiome/Peptidome
High-risk Gastroesophageal Varices
Compensated Cirrhosis
Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis

Study Results

No Results Posted as of Aug 17, 2021